Quality of Awakening and Impact on Cognitive Function After Administration of Sugammadex in Robotic Radical Cystectomy

NCT ID: NCT02454504

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-08-31

Brief Summary

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With the aim of enhancing the quality of surgery, the robotic cystectomy is often conducted using continuous intravenous infusion of curare, which ensures maximum neuromuscular relaxation until the end of the intervention. Sugammadex, administered for the reversal of deep neuromuscular blocked, enable rapid awakening. Moreover, Sugammadex seems to have a positive effect also on the recovery of cognitive function, psychomotor coordination and mental ability, effects undocumented in Literature.

The aim of the investigators study was to assess whether the reversal with sugammadex after intraoperative continuous infusion of rocuronium, can improve the quality of awakening.

Detailed Description

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Conditions

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Anesthesiology Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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sugammadex

this arm will receive sugammadex at the end of the surgery

Group Type ACTIVE_COMPARATOR

sugammadex

Intervention Type DRUG

neostigmine

this arm will receive neostigmine at the end of the surgery

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

Interventions

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sugammadex

Intervention Type DRUG

Neostigmine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA score ≤ III
* Patients underwent robotic cystectomy

Exclusion Criteria

* Cerebrovascular disease
* BMI ≥ 30
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Ester Forastiere

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Regina Elena Cancer Institute

Rome, RM, Italy

Site Status

Countries

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Italy

Other Identifiers

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307.CI

Identifier Type: -

Identifier Source: org_study_id

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